1. Field of the Invention
The present invention relates to an infusion vessel which is capable of separately containing a drug and a infusion liquid in a sterile manner, and mixing the drug with the infusion liquid in a sterile manner by a simple operation for use.
2. Description of Related Art
Conventional infusion vessels of on-demand dissolution type are disclosed, for example, in Japanese Unexamined Patent Publications No. 5-103820 (1993), No. 2-1277 (1990) and No. 60-132561 (1985).
In an infusion vessel disclosed in Japanese Unexamined patent Publication No. 5-103820 (1993), a drug container and a diluent container (liquid container) are independently provided and, as required, are connected in communication with each other. The drug container has a diluent communication port and a drug solution outlet port provided on opposite sides thereof, and seal members are respectively attached to these ports. The diluent container has a connector attachable to the diluent communication port of the drug container. When the infusion vessel is used, caps of the drug container and the diluent container independently provided as shown in FIGS. 2 and 3 in this patent publication are removed, and the drug container and the diluent container are connected to each other. The diluent container is sterilized by means of an autoclave and a drug is filled in the drug container in a sterile room, whereby the insides of the diluent container and the drug container are kept sterile. However, when the drug container and the diluent container are connected to each other for use, the connector and communication means such as a needle are exposed to the atmosphere, so that the connector is liable to be contaminated with bacteria and viruses in the atmosphere. As a result, it is impossible to ensure the sterility of the infusion liquid.
An infusion vessel disclosed in Japanese Unexamined Patent Publication No. 2-1277 (1990) includes a infusion liquid bag (flexible container), a resin capsule connected to an upper portion of the infusion liquid bag via a liquid channel, and a glass vial retained in the capsule. A fracturable rubber plug seals the liquid channel, and a rubber plug also seals a mouth of the vial. A two-tip needle is provided in the liquid channel. For use, the rubber plugs of the vial and the liquid channel are pierced with the needle by pressing down the vial, so that the inside of the vial communicates with the inside of the bag. In order to ensure the sterility of the infusion vessel having such a construction even after the communication is established between the vial and the bag, the two-tip needle and a space between the vial and the capsule should also be kept sterile. After the assembling of the infusion vessel, the space between the vial and the capsule can be sterilized by steam penetrating through the capsule in an autoclave sterilization process. However, the steam is condensed on an interior surface of the capsule after the autoclave process, so that water droplets remain in the capsule. This impairs the product value. Further, it is impossible to employ EO sterilization and electron beam sterilization from the viewpoint of the stability of the drug. Therefore, the entire production process from the filling of a infusion liquid to the assembling should be performed in a sterile atmosphere.
An infusion vessel disclosed in Japanese Unexamined Patent Publication No. 60-132561 (1985) includes a infusion liquid bag having a cylindrical top opening, a plastic sleeve fixed to the cylindrical top opening of the bag by heat-sealing, and a glass sleeve fitted in the plastic sleeve, and is adapted to contain a drug in the glass sleeve. Two rubber plugs are fitted in the glass sleeve, and the drug is contained in a space defined between the rubber plugs. In order to ensure the sterility of the inside of the bag of the infusion vessel having such a construction, it is essential to thoroughly inspect a circumferential portion of the top opening of the bag heat-sealed to the plastic sleeve to check the integrity of the heat seal. This increases quality control costs.